The World Health Assembly adopted the new International Health Regulations on May 23, 2005. The new IHR represent the culmination of a decade-long revision process and an historic development for international law and public health. The new IHR appear at a moment when public health, security, and democracy have become intertwined, addressed at the highest levels of government. The United Nations Secretary-General Kofi Annan, for example, identified IHR revision as a priority for moving humanity toward “larger freedom.” This article (...) analyzes the new IHR and their implications for global health and security in the 21st century.The WHA instructed the WHO Director-General to revise the IHR in 1995 because the Regulations did not provide an effective framework for addressing the international spread of disease. Doubts about the IHR's effectiveness had, however, been present long before 1995. The critiques identified the narrow scope of the regulations, the lack of compliance by states, and the absence of a strategy for responding to rapid changes in public health's global economic and technological environments. (shrink)

In Grimes v. Kennedy Krieger Institute, the Maryland Court of Appeals considered whether it is possible for investigators or research entities to have a special relationship with subjects, thereby creating a duty of care that could, if breached, give rise to an action in negligence. The research under review, the Lead Abatement and Repair & Maintenance Study, was conducted from 1993 to 1996 by investigators at the Kennedy Krieger Institute, an affiliate of Johns Hopkins University.After briefly discussing the case at (...) the center of this ruling, I consider how ambiguities within the federal research regulations at 45 C.F.R. § 46 contribute to disagreements among reasonable and informed people of good will about what studies should be approved. I argue that Grimes may be understood as placing restrictions on how these regulations may be interpreted and used. (shrink)

The study aimed to identify the role of administrative procedures and systems in enhancing the performance of the educational institutions in the Islamic University in Gaza. To achieve the research objectives, the researchers used the analytical descriptive approach to collect information. The researchers used the questionnaire distributed to three categories of employees at the Islamic University (senior management, faculty members, their assistants and members of the administrative board). A random sample of 314 employees was selected and 276 questionnaires were retrieved (...) with a recovery rate of 88.1%. The Statistical Analysis Program (SPSS) was used to enter process and analyze data. The results of the research showed a positive role for the administrative procedures and systems in enhancing the performance of the Islamic University from the point of view of the members (senior management, teaching staff and their assistants and the administrative body), where the relative weight of all the paragraphs (73.728%). The analysis of the results revealed that the administrative procedures at the Islamic University in Gaza are used to an acceptable degree. The relative weight of all the paragraphs is 70%. This indicates a relationship between administrative procedures and regulations and the performance of the Islamic University in the Gaza Strip. The study found that there was a good degree of approval from the sample regarding the administrative procedures and their relationship to the job performance. There exist a sufficient degree of powers to the deans and department managers to carry out their tasks, with the use of plans as control tools. And that there are rules and procedures provided for decision-making in the University Council. It also has full powers to manage the university to improve the teaching and learning environment. The researchers also recommended a number of recommendations, including the need to follow up on the procedures and systems of management and update them continuously in the light of changes that may occur and to ensure the existence of a strong system of electronic information systems within the university. There is a need to provide mechanisms for obtaining information about the surrounding external environment, and effective mechanisms to provide managers with the necessary information in a timely manner. The importance of providing channels of communication that enables staff to communicate information about any violations and breaches. The study also recommended the follow-up, review, procedures and administrative systems, and work to modify them in line with the mission of the university and the objectives that the university seeks to reach. (shrink)

In Grimes v. Kennedy Krieger Institute, the Maryland Court of Appeals considered whether it is possible for investigators or research entities to have a special relationship with subjects, thereby creating a duty of care that could, if breached, give rise to an action in negligence. The research under review, the Lead Abatement and Repair & Maintenance Study, was conducted from 1993 to 1996 by investigators at the Kennedy Krieger Institute, an affiliate of Johns Hopkins University.After briefly discussing the case at (...) the center of this ruling, I consider how ambiguities within the federal research regulations at 45 C.F.R. § 46 contribute to disagreements among reasonable and informed people of good will about what studies should be approved. I argue that Grimes may be understood as placing restrictions on how these regulations may be interpreted and used. (shrink)

The recent global increase in environmental regulation does not necessarily signal improvement in firms’ ecological imprints. Like many markets, the Arab world is struggling to implement environmental compliance measures among local firms. For Arab countries, the reliance solely on formal policies to improve local firms’ ecological footprints may be risky given the evident institutional challenges to enforce environmental regulations, specially post the Arab Spring. Drawing from the literature highlighting the merits of combining formal and informal controls to ensure successful (...) implementation of a strategy, we argue that the emphasis for regulation must be accompanied by an emphasis for developing environmental ethics of individuals, who are the expected implementers of any environmental policy. In that light, we propose that the Eco-Islam phenomenon can serve as an influential and effective foundation for building organizational cultures with stronger environmental ethics among local small and medium enterprises. We explain the underlying maxims of Eco-Islam then conduct qualitative research among experts preaching or practicing the concept to gain better insights into the potential of leveraging it in Muslim-majority Arab countries. Finally, we conclude with insightful implications for local SMEs in the region. (shrink)

The purpose of this study was to extend the knowledge about why procedural justice has behavioral implications within organizations. Since prior studies show that PJ leads to legitimacy, the author suggests that, when formal regulations are unfairly implemented, they lose their validity or efficacy. This “rule deactivation,” in turn, leads to two proposed destructive work behaviors, namely, workplace deviance and decreased citizenship behaviors. The results support this mediating role of RD, thus suggesting that it forms part of the generative (...) mechanism through which unfair procedures influence ethical behavior within organizations. The author ends the article by discussing behavioral ethics and managerial implications as well as suggestions for future research. (shrink)

In ‘Obesity, equity and choice’, Timothy Wilkinson argues that preventive regulations to address obesity, such as taxes on sugary drinks, are at worst inequitable and at best fail to increase or improve equity. He concludes that we do not yet have good reasons to adopt them. I argue that equity considerations are not as problematic for preventive regulations as Wilkinson suggests.

Emergency medicine research requires the enrollment of subjects with varying decision-making capacities, including capable adults, adults incapacitated by illness or injury, and children. These different categories of subjects are protected by multiple federal regulations. These include the federal Common Rule, the Department of Health and Human Services (DHHS) regulations for pediatric research, and the Food and Drug Administration's (FDA) Final Rule for the Exception from the Requirements of Informed Consent in Emergency Situations. Investigators should be familiar with the (...) relevant federal research regulations to optimally protect vulnerable research subjects, and to facilitate the institutional review board (IRB) review process. IRB members face particular challenges in reviewing emergency research. No regulations exist for research enrolling incapacitated subjects using proxy consent. The wording of the Final Rule may not optimally protect vulnerable subjects. It is also difficult to apply conflicting regulations to a single study that enrolls subjects with differing decision-making capacities. This article is intended as a guide for emergency researchers and IRB members who review emergency research. It reviews the elements of Federal Regulations that apply to consent, subject selection, privacy protection, and the analysis of risks and benefits in all emergency research. It explores the challenges for IRB review listed above, and offers potential solutions to these problems. (shrink)

Farming of fish and other aquatic species has increased in recent decades and never before have there been more controversial debates on animal welfare in fish husbandry. The practices used and associated welfare issues are becoming increasingly focused on by scientists, consumers and policy makers. International and national organisations have issued recommendations and guidelines concerning fish welfare but there is still a lot of information lacking. Due to § 2 of the German animal protection law, animals must be adequately nourished, (...) cared for and behaved in a proper manner, and pain or avoidable suffering or damage must be avoided. Keeping fish in accordance with the animal protection laws should be part of a good professional aquaculture practice and is indispensable for ethical, legal and economic reasons. As other vertebrates fish have the right of a healthy life with physical and mental integrity, under which they can perform adequately.The paper provides and discusses legal aspects of animal protection applied to fish taking the German welfare act and EU regulations as example. First possible indicators for the assessment of well-being will be mentioned. The assessment of fish welfare indicators should be carried out within the frame of daily and regular working routines, e. g. feeding, harvesting, grading or slaughtering. Further customer’s perception and human interpretation of welfare in fish are discussed and set into the context of human sentiments, projected on fish and the debate on consciousness in fish. (shrink)

The House of Lords majority decision in Matthews v. Kent and Medway Towns Fire Authority overturns the narrow interpretation given to key aspects of the Part-Time Workers (Protection of Less Favourable Treatment) Regulations’ core comparator mechanism in the lower tribunals and the Court of Appeal. It is a contextually astute judgment, which recognises the reductionist implications of an overly narrow approach to establishing comparability for the purposes of a less favourable treatment claim on the grounds of part-time work. The (...) positive aspect of this decision remains overshadowed, however, by the fact that this interpretation provides little consolation to the large majority of part-time women workers whose disadvantage and inequality remains outside the scope of the Regulations’ protection. (shrink)

Ethical principles play an important part not only in the promulgation of regulations but also in their application, i.e., enforcement and adjudication. While traditional ethical principles – promotion of welfare, freedom, and fairness – play an important role in both elements of regulation, some other kinds of ethical principles are significant as well. Principles governing the structure of decision processes should shape the structure and actions of agencies; principles of wise application should govern the work of those whose responsibility (...) it is to apply regulatory language to particular situations. These points are demonstrated by investigating a case study: federal regulations designed to protect children involved in scientific research applied to a placebo study of the effects of recombinant human growth hormone on children of extremely short stature. Keywords: ethics, interpretation, regulation, research CiteULike Connotea Del.icio.us What's this? (shrink)

The purpose of this study was to extend the knowledge about why procedural justice (PJ) has behavioral implications within organizations. Since prior studies show that PJ leads to legitimacy, the author suggests that, when formal regulations are unfairly implemented, they lose their validity or efficacy (becoming deactivated even if they are formally still in force). This "rule deactivation," in turn, leads to two proposed destructive work behaviors, namely, workplace deviance and decreased citizenship behaviors (OCBs). The results support this mediating (...) role of PJD, thus suggesting that it forms part of the generative mechanism through which unfair procedures influence (un) ethical behavior within organizations. The author ends the article by discussing behavioral ethics and managerial implications as well as suggestions for future research. (shrink)

United States federal regulations for pediatric research with no prospect of direct benefit restrict institutional review board (IRB) approval to procedures presenting: 1) no more than "minimal risk" (§ 45CFR46.404); or 2) no more than a "minor increase over minimal risk" if the research is commensurate with the subjects' previous or expected experiences and intended to gain vitally important information about the child's disorder or condition (§ 45CFR46.406) (DHHS 2001). During the 25 years since their adoption, these regulations (...) have helped IRBs balance subject protections with the pursuit of scientific knowledge to advance children's welfare. At the same time, inconsistency in IRB application of these regulations to pediatric protocols has been widespread, in part because of the ambiguity of the regulatory language. During the past decade, three federally-charged committees have addressed these ambiguities: 1) the National Human Research Protections Advisory Committee (NHRPAC) (Washington, DC), 2) the Institute of Medicine (IOM) Committee on the Ethical Conduct of Clinical Research Involving Children (Washington, DC); and 3) the United States Department of Health and Human Services Secretary's Advisory Committee for Human Research Protections (SACHRP) (Washington, DC). The committees have reached similar conclusions on interpretation of language within regulations § § 45CFR46.404 and 406; these conclusions are remarkably consistent with recent international recommendations and those of the original National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research (1977) report from which current regulations are based. Drawing on the committees' public reports, this article identifies the ethical issues posed by ambiguities in regulatory language, summarizes the committees' deliberations, and calls for a national consensus on recommended criteria. (shrink)

The purpose of the present discussion is to present, reflect upon, and evaluate the effective legal regulations concerning the obligation to terminate a medical experiment. The considerations made herein aim at providing an answer to the question whether the aforesaid legal regulations are clear and sufficient. The said analysis is based on the following source: The Act of 5 December 1996 concerning the Professions of General Practitioner and Dental Practitioner. The regulations concerning the obligation to discontinue a (...) medical experiment, both by the will of the participant and on the physician’s initiative, are of great importance owing to the fact that they guarantee protection of the patients taking part in the experimental study. The provisions implicitly oblige the physician to monitor the patients’ state of health and conduct constant assessment whether or not further carrying on the experiment is expedient and admissible. The legal regulations effective in Poland are explicit and sufficient. Their wording does not raise any considerable reservations. As it appears, the legislature managed to work out appropriate rules so as to minimize the danger zone for the participants of clinical tests and at the same time implement a guarantee that participants’ rights shall be respected. (shrink)

Investigates the resolution of contradictions and ambiguous derogations in a code, by means of the imposition of partial orderings.

Background We present and discuss the results of a Norwegian survey of medical doctors' views on potential ethical dilemmas in professional practice. Methods The study was conducted in 2015 as a postal questionnaire to a representative sample of 1612 doctors, among which 1261 responded. We provided a list of 41 potential ethical dilemmas and asked whether each was considered a dilemma, and whether the doctor would perform the task, if in a position to do so. Conceptually, dilemmas arise because of (...) tensions between two or more of four doctor roles: the patient’s advocate, a steward of societal interests, a member of a profession and a private individual. Results 27 of the potential dilemmas were considered dilemmas by at least 50% of the respondents. For more than half of the dilemmas, the anticipated course of action varied substantially within the professional group, with at least 20% choosing a different course than their colleagues, indicating low consensus in the profession. Conclusions Doctors experience a large range of ethical dilemmas, of which many have been given little attention by academic medical ethics. The less-discussed dilemmas are characterised by a low degree of consensus in the profession about how to handle them. There is a need for medical ethicists, medical education, postgraduate courses and clinical ethics support to address common dilemmas in clinical practice. Viewing dilemmas as role conflicts can be a fruitful approach to these discussions. (shrink)

It is well known that totem worship is an early product of human society, from which it can be argued that East and West share a common cultural origin, although totem worship cannot be identified as the initial origin of all human civilizations, it is the common premise from which all subsequent clans, tribes, and groups emerged. When societies face upheaval and change and breed conflict and chaos, salvation may be found in the common cultural origins of humankind. This paper (...) argues that both Durkheim and Confucius when faced with social anomie caused by the "crisis of European civilization" and the "collapse of ritual and music" (Libeng Yuehuai禮崩樂壞) respectively, traced their roots back to the sacredness of primitive witchcraft activities, including totem worship and the law of taboos, as the elixir of "healing" the society, which is "the same way"; However, due to the inherent differences in cultural background and subjectivity, the two have embarked on different paths of development and formed different social paradigms and interpersonal relationships, which are "different returns". (shrink)

Scholars and policymakers continue to struggle over the meaning of the word “vulnerable” in the context of research ethics. One major reason for the stymied discussions regarding vulnerable populations is that there is no clear distinction between accounts of research vulnerabilities that exist for certain populations and discussions of research vulnerabilities that require special regulations in the context of research ethics policies. I suggest an analytic process by which to ascertain whether particular vulnerable populations should be contenders for additional (...) regulatory protections. I apply this process to two vulnerable populations: the cognitively vulnerable and the economically vulnerable. I conclude that a subset of the cognitively vulnerable require extra protections while the economically vulnerable should be protected by implementing existing regulations more appropriately and rigorously. Unless or until the informed consent process is more adequately implemented and the distributive justice requirement of the Belmont Report is emphasized and operationalized, the economically disadvantaged will remain particularly vulnerable to the harm of exploitation in research. (shrink)

The number of legal and nonlegal ethical regulations in the biomedical field has increased tremendously, leaving present-day practitioners and researchers in a virtual crossfire of legislations and guidelines. Judging by the production and by the way these regulations are motivated and presented, they are held to be of great importance to ethical practice. This view is shared by many commentators. For instance, Commons and Baldwin write that, within the nursing profession, patient care can be performed unethically or ethically (...) depending on the professional standards the nurses have set for themselves. They also hold that such standards are set when nurses become aware of the ethical codes available. As nurses are often not familiar with the codes, they do not all conform to them. Commons and Baldwin argue that nurses' ability to deal with ethical dilemmas is effectively secured with education on guidelines, creating a “barrier” between personal and professional values. (shrink)

Recent state regulations require women, before undergoing abortions, to be subjected to unwanted and nonmedically necessary sonograms, often requiring an intrusive vaginal probe. Physicians, for their part, are forced to turn the viewing screens toward the faces of their patients and to describe to them the details on the screen. In this commentary, I explain these current laws and the various court responses to them to date. Further, I demonstrate why these abortion regulations violate the ethical principles governing (...) informed consent and why they should be declared unconstitutional based on women’s constitutional rights as settled by Planned Parenthood of Southeastern Pennsylvania v. Casey and physicians’ First Amendment rights. (shrink)

In Germany — as probably worldwide — in vitro fertilization has provoked disapproval, fears, and dread, but it also raises hope and gives feelings of pride and satisfaction in a new scientific achievement. Critics look for convincing argu- ments that could ban IVF completely or at least restrict it considerably. Some of the most important arguments are outlined below.The main aspect of IVF that was new to society was that conception could take place outside the female body. Although this fact (...) has made a deep impression on us, no ethical relevance has been attributed to it. One must look further for arguments against IVF. (shrink)

In Islamic law paternity is treated as a consequence of a licit sexual relationship. Since DNA testing makes a clear distinction between legal and biological paternity possible, it challenges the continued correlation between paternity and marriage. This article explores the foundations of paternity regulations in the Islamic ethico-legal tradition, with a particular focus on what is termed here “the licit sex principle,” and investigates the extent to which a harm-based argument can be made either by appeal to or against (...) Islamic paternity regulations. It argues that in Islamic bioethics the definition of harm and its boundaries is a function of both: (1) identification of legal and religious rights and the extent to which these rights are violated; and (2) balancing and reconciling perceived harm against both specific principles in relation to a given issue and also the overarching objectives of Islamic law. The article is divided into three main sections addressing the Islamic legal, ethical, and bioethical dimensions of paternity. (shrink)

The ethical (and philosophical) issues arising in citizen science are fascinating, challenging, and potentially pathbreaking in that they force us to reconsider the conceptual and regulatory catego...

Organ donation after a circulatory determination of death is possible in selected patients where consent is given to support donation and the patient has been legally declared dead by two doctors. The National Health Act (61 of 2003) and regulations provide strict controls for the certification of death and the donation of organs and tissues after death. Although the National Health Act expressly recognises that brain death is death, it does not prescribe the medical standards of testing for the (...) determination of brain death (neurological determination of death), circulatory death (circulatory determination of death) or for determination of death based on somatic criteria. However, in all cases of organ donation, including after circulatory death, the National Health Act mandates that two doctors certify the death, with one doctor possessing more than 5 years of experience. Additionally, both doctors must be independent from the transplant team. The standard for such determination, as for brain death, aligns with accepted medical standards. The Critical Care Society of Southern Africa has published South African (SA) Guidelines on Death Determination that outline rigorous standards for death determination in hospital settings by either a neurological or circulatory method. Legislation and the Health Professions Council of SA’s (HPCSA) professional guidance direct clinicians on obtaining informed consent for donation either from the patient or in cases of incapacity from their surrogate decision maker. Collectively, the legislation, regulations and professional guidelines in SA provide a robust ethical framework that supports organ donation after circulatory death. (shrink)

Federal regulations require that the level of risk posed by pediatric research be classified as “minimal,” “greater than minimal,” or “a minor increase over minimal.” Interpretation of the meaning of the levels has produced a significant literature exploring the ethical basis for making these determinations. This article examines the ethical basis of a variety of approaches proposed in the literature for classifying pediatric research risk. These approaches strive to take into account how society decides which risks are routinely accepted (...) for children outside of research. It is concluded that ways of classifying risk should compare research risks to normal risks for children without special disability and take into account the concerns of the research subject’s community. (shrink)

Ethical concerns in e-social science are often raised with respect to privacy, confidentiality, anonymity and the ethical and legal requirements that govern research. In this article, the authors focus on ethical aspects of e-research that are not directly related to ethical regulatory framework or requirements. These frameworks are often couched in terms of benefits or harms that can be incurred by participants in the research. The authors shift the focus to the sources of value in terms of which benefits or (...) harms are understood in real social situations. A central claim of this paper is that the technologies that are used for research are not value neutral, but serve to reinforce some values at the expense of others. The authors discuss databases, modelling and simulation, network analysis as examples of technologies which affect the articulation of values. A view of e-social science as a techno-scientific constellation of researchers, technologies and society, in which values are always already embedded, is put forward as a basis for a view of ethics as reflexive and active engagement, conducted with awareness. Methodological pluralism and proactive openness are also proposed as responses to this view of the ethical dimensions of e-social science. (shrink)

Deception is a useful methodological device for studying attitudes and behavior, but deceptive studies fail to fulfill the informed consent requirements in the U.S. federal regulations. This means that before they can be approved by Institutional Review Boards, they must satisfy the four regulatory conditions for a waiver or alteration of these requirements. To illustrate our interpretation, we apply the conditions to a recent study that used deception to show that subjects judged the same wine as more enjoyable when (...) they believed it had a higher price. (shrink)

Ethical concerns in e-social science are often raised with respect to privacy, confidentiality, anonymity and the ethical and legal requirements that govern research. In this article, the authors focus on ethical aspects of e-research that are not directly related to ethical regulatory framework or requirements. These frameworks are often couched in terms of benefits or harms that can be incurred by participants in the research. The authors shift the focus to the sources of value in terms of which benefits or (...) harms are understood in real social situations. A central claim of this paper is that the technologies that are used for research are not value neutral, but serve to reinforce some values at the expense of others. The authors discuss databases, modelling and simulation, network analysis as examples of technologies which affect the articulation of values. A view of e-social science as a techno-scientific constellation of researchers, technologies and society, in which values are always already embedded, is put forward as a basis for a view of ethics as reflexive and active engagement, conducted with awareness. Methodological pluralism and proactive openness are also proposed as responses to this view of the ethical dimensions of e-social science. (shrink)

This is the first re-publication and first English translation of regulations concerning Human Experimentation which were binding law prior to and during the Third Reich, 1931 to 1945. The introduction briefly describes the duties of the Reichsgesundheitsamt, which formulated these regulations. It then outlines the basic concept of the Richtlinien for protecting subjects and patients on the one hand and for encouraging New Therapy and Human Experimentation on the other hand. Major issues, like personal responsibility of the physician (...) or researcher, teaching of ethics of research and therapy, and research and therapy on vulnerable populations, are compared with the regulations in the Nuremberg Code and subsequent regulations influenced by the Nuremberg Code. CiteULike Connotea Del.icio.us What's this? (shrink)

On December 17, 1999, President Clinton signed the Ticket to Work and Work Incentives Improvement Act of 1999, which instituted a 90-day comment period for the amended Organ Procurement and Transplantation Network Final Rule, a comprehensive set of guidelines that would affect how organs are allocated throughout the country. Barring further legislative action, the Final Rule, which has been over five years in the making, will be effective on March 16,2000.The Final Rule, issued by the Department of Health and Human (...) Services pursuant to the National Organ Transplant Act, was originally publishedApril 2, 1998. It provided a number of substantive changes to the process through which organs are allocated by the United Network for Organ Sharing, a private, non-profit organization charged with administering the national organ transplantation network. (shrink)

On December 17, 1999, President Clinton signed the Ticket to Work and Work Incentives Improvement Act of 1999, which instituted a 90-day comment period for the amended Organ Procurement and Transplantation Network Final Rule, a comprehensive set of guidelines that would affect how organs are allocated throughout the country. Barring further legislative action, the Final Rule, which has been over five years in the making, will be effective on March 16,2000.The Final Rule, issued by the Department of Health and Human (...) Services pursuant to the National Organ Transplant Act, was originally publishedApril 2, 1998. It provided a number of substantive changes to the process through which organs are allocated by the United Network for Organ Sharing, a private, non-profit organization charged with administering the national organ transplantation network. (shrink)

This paper examines the drive for consensus from the perspective of the good government framework for federal advisory commissions in the United States. Specifically, the paper examines the Federal Advisory Committee Act (FACA) – the statute, its regulations, and case law. It shows that the FACA was intended to be an antidote to abuses in consensus‐making processes, including the failure to fully include competing views on commissions. The index of suspicion in the FACA scheme rises when a group work (...) product – including a consensus report – is to be the basis of recommendations to federal officials. Once FACA's requirements regarding committee composition are satisfied, the index of suspicion drops and FACA is indifferent to consensus‐making; but the conditions for informed, meaningful participation apply to members who dissent from, as well as those who participate in, consensus. In negotiated rulemaking, the push for consensus and closure creates unacceptable tension with the good government goals of openness and accountability. Proponents of consensus‐only bioethics commissions can learn from FACA‐related legislative, agency, and judicial insights that consensus‐seeking is not always desired by government officials; is rarely cost free; and that diversity and dissent enhance openness, accountability, and fairness. The burden of proof is therefore on proponents of a consensus‐only standard for bioethics commissions to demonstrate that a drive for consensus furthers sound decision‐making by government officials more than it sets back openness and accountability to a diverse public. (shrink)

This paper examines the drive for consensus from the perspective of the good government framework for federal advisory commissions in the United States. Specifically, the paper examines the Federal Advisory Committee Act (FACA) – the statute, its regulations, and case law. It shows that the FACA was intended to be an antidote to abuses in consensus‐making processes, including the failure to fully include competing views on commissions. The index of suspicion in the FACA scheme rises when a group work (...) product – including a consensus report – is to be the basis of recommendations to federal officials. Once FACA's requirements regarding committee composition are satisfied, the index of suspicion drops and FACA is indifferent to consensus‐making; but the conditions for informed, meaningful participation apply to members who dissent from, as well as those who participate in, consensus. In negotiated rulemaking, the push for consensus and closure creates unacceptable tension with the good government goals of openness and accountability. Proponents of consensus‐only bioethics commissions can learn from FACA‐related legislative, agency, and judicial insights that consensus‐seeking is not always desired by government officials; is rarely cost free; and that diversity and dissent enhance openness, accountability, and fairness. The burden of proof is therefore on proponents of a consensus‐only standard for bioethics commissions to demonstrate that a drive for consensus furthers sound decision‐making by government officials more than it sets back openness and accountability to a diverse public. (shrink)

Cohen’s article (2023) on the significance of ChatGPT for bioethics suggests that little is known about the development of generative AI (“GAI”) in China and other national markets. It warns about...

The second of five commentaries on “Bloomberg's Health Legacy: Urban Innovator or Meddling Nanny?” from the September‐October 2013.